title: Successful use and dosing of bivalirudin after temporary total artificial heart implantation: a case series.
abstract: The temporary total artificial heart (TAH-t) has emerged as an effective bridge to transplantation for individuals with biventricular failure. Implantation of a TAH-t creates a hypercoagulable state requiring a multidrug approach that includes low-dose unfractionated heparin (UFH) in order to minimize thromboembolism. A concern with UFH is the development of heparin-dependent antibodies, which develop in up to 50% of patients receiving the drug as part of cardiopulmonary bypass. If UFH therapy continues postoperatively, the risk of heparin-induced thrombocytopenia approaches 3%. Small investigations have demonstrated that bivalirudin, given as a bolus of 0.75-1 mg/kg followed by an infusion at 1.75-2.5 mg/kg/hour, is an effective alternative to UFH for therapeutic anticoagulation during coronary artery bypass surgery, valve replacement, or both. We describe a series of five adults (age range 24-58 yrs) who received bivalirudin as an alternative to low-dose UFH after TAH-t implantation. None of the patients had documented heparin-induced thrombocytopenia. Treatment was started at the discretion of the treating physician, and adjustments were based principally on the results of thromboelastography. Additional general monitoring included activated partial thromboplastin time, prothrombin time, international normalized ratio, fibrinogen, D-dimer, platelet count, hemoglobin, hematocrit, and platelet aggregation studies. Bivalirudin therapy was continued until successful warfarin implementation. All five patients received bivalirudin in addition to standard antithrombotic therapy. Bivalirudin treatment started at a dosage of 0.005 or 0.01 mg/kg/hour with titration to maintain normocoagulability, which occurred (without concomitant warfarin therapy) within the dosage range of 0.01-0.02 mg/kg/hour. Duration of TAH-t implantation was a mean of 38.8 days (range 25-60 days), and bivalirudin was continued for a mean of 15.2 days (range 7-24 days). No major hemorrhagic events occurred during treatment, and all patients successfully transitioned to warfarin therapy. Low-dose bivalirudin, as an alternative to UFH, maintained normocoagulability after TAH-t implantation. Further investigation is warranted to define the role and dosing of bivalirudin in this situation.
authors.affiliation: South University School of Pharmacy, Department of Pharmacy Practice, 709 Mall Boulevard, Savannah, GA 31406-4805, USA. mcrouch@southuniversity.edu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Crouch
authors.forename: Vigeshwar
authors.initials: V
authors.lastname: Kasirajan
authors.forename: William
authors.initials: W
authors.lastname: Cahoon
authors.forename: Gundars J
authors.initials: GJ
authors.lastname: Katlaps
authors.forename: Kyle J
authors.initials: KJ
authors.lastname: Gunnerson
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage* / Q000627:therapeutic use*; D000991:Antithrombins / Q000008:administration & dosage* / Q000627:therapeutic use*; D002311:Cardiomyopathy, Dilated / Q000601:surgery; D016027:Heart Transplantation; D006354:Heart, Artificial; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D007431:Intraoperative Complications / Q000097:blood / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000601:surgery; D010314:Partial Thromboplastin Time; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000627:therapeutic use*; D019919:Prosthesis Implantation; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin